NCT06926647

A Real-World Study of Antiviral Therapy in Children With Chronic Hepatitis B

A Multicenter, Prospective, Real-World Study of Antiviral Therapy in Children With Chronic Hepatitis B

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Beijing 302 Hospital · Academic / Other
• Sex: All
• Age: 1 Year – 13 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, prospective, real-world study. The study plans to include a total of 2000 patients who meet the inclusion and exclusion criteria, consisting of 1600 treatment-naive patients and 400 treatment-experienced patients. The effectiveness and safety of different treatment strategies will be evaluated in children aged 1-12 years with treatment-naive and treatment-experienced chronic hepatitis B (CHB) and chronic HBV infection.

Conditions

• HBV
• Chronic Hepatitis b

Interventions

Type	Name	Description
DRUG	Nucleos(t)ide Analogues	Administer NAs \[LAM, ETV, TDF, TAF (TAF preferred for those aged 6 years and older)\] continuously for 48 weeks based on age.
DRUG	Interferon alfa	IFNα monotherapy for 48 weeks (select conventional IFNα for ages ≥1 and \<3 years, select PEG-IFNα-2b for ages ≥3 years)
DRUG	NAs combined with IFNα	Receive NAs combined with IFNα treatment for 48 weeks.
OTHER	comparative observation	Blank control observation for 48 weeks.
OTHER	drug withdrawal observation	This group is the drug withdrawal observation group, which will strictly monitor virological indicators and biochemical results, and will reinitiate antiviral treatment if necessary based on antiviral treatment standards and the willingness of the child (or family members)

Timeline

• Start date: 2025-05-01
• Primary completion: 2028-12-15
• Completion: 2028-12-31
• First posted: 2025-04-14
• Last updated: 2025-04-29

Locations

85 sites across 1 country: China